drugset / Trial / NCT01478074
ALT-801-activated Natural Killer Cells After FLAG Induction for Acute Myeloid Leukemia
NaSingle-groupOpen-labelTreatment
Summary
This is a single-center open-label phase I clinical trial of delivering haploidentical natural killer (NK) cells matured ex vivo with ALT-801 followed by intravenous infusions of ALT-801 in patients with relapsed/refractory Acute Myeloid Leukemia (AML). The study will be conducted at M.D. Anderson Cancer Center (MDACC) and MDACC Children's Cancer Hospital in Houston, Texas.
Timeline
- Start
- 2011-11
- Primary completion
- 2013-10
- Completion
- 2013-11
Outcome
Outcome not reported
Stopped (Enrollment): “The treatment planned was determined to be of low feasibility as no subject was found eligible and able to enroll after screening over 30 subjects”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ALT-801 | Protein / enzyme biologic | 0.04 mg/kg | Intravenous |
| Subject | Donor Natural Killer (NK) cells | Cell therapy | 0 cells/kg | — |
| Subject | Donor Natural Killer (NK) cells | Cell therapy | 1e+06 cells/kg | — |
| Subject | Donor Natural Killer (NK) cells | Cell therapy | 1e+07 cells/kg | — |
| Subject | Donor Natural Killer (NK) cells | Cell therapy | 2e+07 cells/kg | — |
| Background | Cytarabine | Small molecule | 2 g | — |
| Background | Fludarabine | Small molecule | 30 mg/m2 | — |
| Background | G-CSF | Unknown | 5 ug/kg | — |